1

Iso 11607 Jobs in Wisconsin (NOW HIRING)

Review batch records thoroughly to verify accuracy, completeness, and compliance with GMP, FDA, and ISO requirements. * Inspect and approve incoming raw materials to ensure they meet established ...

Quality Engineer

Menomonee Falls, WI · On-site

$72K - $93K/yr

Act as the primary auditor for internal quality audits in accordance with IATF16949, ISO 9001, and ISO 14001 requirements. * Facilitate, recommend, and implement effective corrective actions by ...

Review batch records thoroughly to verify accuracy, completeness, and compliance with GMP, FDA, and ISO requirements. * Inspect and approve incoming raw materials to ensure they meet established ...

FDA 21 CFR 820, ISO 13485, etc.) * Ensuring auditing and manufacturing documentation is kept up to date. * Review of Intech document to ensure company's processes comply with Quality System (QS ...

Quality Engineer

Burlington, WI

$76K - $98K/yr

Lead internal and external audits to ensure compliance with applicable quality standards and regulations, supporting ISO 9001 and AS9100D certification activities. * Provide training, guidance, and ...

New

Review operator's aseptic behavior within the ISO 5 core and adjacent classified areas and escalate any concerns to the operator or their supervisor. * Observe and document real-time activities ...

Quality Engineer 1

Cudahy, WI · On-site

$70K - $91K/yr

Maintain and support the continuous improvement of the company's Quality Management System (QMS) in accordance with ISO 9001 requirements. * Participate in internal and external quality audits and ...

Support and coordinate internal, customer, and certification audits of the Quality Management System (QMS) * Assist in maintaining compliance with ISO 13485:2016, ISO 9001, and/or IATF 16949 ...

Review operator's aseptic behavior within the ISO 5 core and adjacent classified areas and escalate any concerns to the operator or their supervisor. * Observe and document real-time activities ...

Support and coordinate internal, customer, and certification audits of the Quality Management System (QMS) * Assist in maintaining compliance with ISO 13485:2016, ISO 9001, and/or IATF 16949 ...

WI · On-site

$120 - $140/hr

Oversee ISO 9001:2015 certification activities, including audits and corrective actions. * Maintain calibration requirements for all tools and gauges. * Share best practices across Toro locations and ...

Quality Engineer

Port Washington, WI · On-site

$68K - $87K/yr

Proven experience with ISO and IATF standards and quality management systems. * Proven experience with formal auditing * Strong knowledge and application of Statistical Process Control (SPC) and ...

Showing results 21-40

Iso 11607 information

What is the difference between Iso 11607 vs Packaging Technician?

AspectIso 11607Packaging Technician
CertificationsStandards for sterile packagingOften certified in packaging processes
Work EnvironmentManufacturing and sterile packaging facilitiesPackaging lines, production areas
Industry UsageMedical device and pharmaceutical packagingMedical device, pharmaceutical, and consumer goods
Primary FocusEnsuring packaging meets sterilization and safety standardsAssembling, inspecting, and packaging products

While Iso 11607 refers to standards for sterile packaging, a Packaging Technician focuses on executing packaging processes according to those standards. The technician ensures products are properly packaged, inspected, and ready for sterilization, aligning with Iso 11607 requirements to ensure safety and compliance.

What challenges do professionals face when working with ISO 11607 compliance?

Professionals ensuring ISO 11607 compliance often face challenges in interpreting and applying the standard’s requirements to a variety of packaging materials and processes. Keeping up with evolving regulatory expectations, conducting thorough risk assessments, and validating packaging systems can be complex and time-consuming. Collaboration with cross-functional teams including R&D, quality assurance, and manufacturing is crucial to ensure that all packaging meets both regulatory and functional standards. Additionally, maintaining detailed documentation and responding to audit findings are key parts of the role.

What is ISO 11607?

ISO 11607 is an international standard that specifies requirements and test methods for packaging materials and systems used to sterilize medical devices. It ensures that packaging maintains sterility up to the point of use and provides guidance on validation processes. The standard is divided into two parts: Part 1 covers requirements for materials and design, while Part 2 focuses on packaging process validation. Compliance with ISO 11607 is critical for manufacturers to ensure patient safety and meet regulatory requirements.

What skills and qualifications are needed to work with ISO 11607?

To thrive as an ISO 11607 Compliance Specialist, you need expertise in packaging validation, regulatory standards for sterile medical devices, and a background in engineering, quality assurance, or a related scientific field. Familiarity with technical tools such as validation protocols, statistical analysis software, and document control systems is typically required, as well as knowledge of ISO 11607-1 and ISO 11607-2 standards. Strong attention to detail, analytical thinking, and effective communication help ensure compliance and successful collaboration with cross-functional teams. These skills ensure that medical device packaging meets regulatory requirements, safeguarding patient safety and supporting product quality.
What are popular job titles related to Iso 11607 jobs in Wisconsin? For Iso 11607 jobs in Wisconsin, the most frequently searched job titles are:
What cities in Wisconsin are hiring for Iso 11607 jobs? Cities in Wisconsin with the most Iso 11607 job openings:

QA & Regulatory Compliance Specialist

Bassett Mechanical

Kaukauna, WI • On-site

Full-time

Re-posted 18 days ago


Bassett Mechanical rating

8.7

Company rating: 8.7 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

27th of 278 rated repair and maintenance companies


Job description

Bassett Mechanical is a 3rd generation family-owned company that provides custom-built industrial refrigeration, HVAC, plumbing, metal fabricating and preventative maintenance service solutions to customers throughout the United States and the world. It is not only a great place to grow and thrive in your career. It is a place to truly belong. As a member of the Bassett Mechanical Team, you'll enjoy a competitive compensation and benefits package and many professional growth opportunities. From the moment you're hired, to the day you retire, you're a part of our Bassett Mechanical Team. 

Position Purpose

The Quality Assurance and Regulatory Compliance Specialist oversees the company’s quality systems and regulatory compliance activities, ensures alignment with ISO standards and applicable requirements, maintains and administers document control systems, and works collaboratively across the organization. 

This role plays a critical part in identifying quality issues, coordinating internal and external audits, managing corrective actions, and supporting compliance readiness. The role also emphasizes documentation, training, and sustained adherence to regulatory and quality requirements across the organization.

Position Responsibilities

  • Quality Assurance
    • Provide strategic guidance on ISO compliance and ensure alignment with standards.
    • Monitor and manage the quality action system to ensure timely resolution of issues.
    • Lead root cause analysis and develop corrective actions for non-conformities.
    • Analyze quality trends and collaborate with teams to implement preventive measures.
  • Internal and External Audit Leadership
    • Coordinate scheduling and preparation for ISO and other external customer/regulatory audits.
    • Lead the internal audit team and perform internal audits.
    • Develop and maintain audit documentation and train internal auditors.
    • Track and oversee the resolution of audit findings to ensure compliance.
  • Documentation 
    • Maintain and oversee document control systems, ensuring accuracy and accessibility of records.
    • Manage document change requests and approval workflows.
    • Create and update quality documentation, including procedures and work instructions. 
  • Regulatory Compliance
    • Monitor regulatory requirements and internal obligations to ensure ongoing compliance across applicable quality systems.
    • Support regulatory inspections, customer requirements, and compliance assessments by coordinating documentation and evidence.
    • Partner with internal teams to address compliance gaps, implement corrective actions, and maintain readiness for audits and reviews.
    • Promote awareness of regulatory obligations through training, documentation updates, and standardized compliance practices.
  • Collaboration and Reporting
    • Partner with cross-functional teams to address quality issues and share findings.
    • Prepare and present reports on quality trends, audit outcomes, compliance status, and corrective actions to leadership.
    • Act as a liaison between departments to align quality goals with organizational objectives.
  • Support and maintain a safe and Lean work environment.
  • Other duties as assigned.

Summary of Skills, Knowledge and Abilities

  • Bachelor’s degree in Quality Management, Regulatory Affairs, or a related field (preferred) or equivalent experience.
  • 3+ years of experience in quality assurance, regulatory compliance, auditing, or related roles.
  • Proven experience with ISO standards (e.g., ISO 9001) and internal auditing.
  • Strong understanding of quality management systems, regulatory requirements, and compliance methodologies.
  • Demonstrated leadership in coordinating audits and testing processes.
  • Proficiency in Microsoft Office Suite and quality management software.
  • Exceptional organizational, analytical, and problem-solving skills.
  • Effective communication and collaboration abilities across diverse teams.
  • Proactive and results-oriented with a strong compliance and accountability mindset.
  • Flexible and adaptable to dynamic organizational needs.
  • Committed to professional growth and staying current with industry trends 

Direct Reports

  • None
Employment Type: FULL_TIME

What Bassett Mechanical employees say

Pay

Hours and flexibility

Workplace

Get the full story on Breakroom